Medical device recall in Canada: Fabian ventilators may cause serious injury
In plain language
This recall involves Fabian HFO, +nCPAP evolution, and Therapy evolution ventilators sold in Canada. They are being recalled because a power board defect can cause the ventilator to shut down without an alarm. This could lead to serious injury or death due to lack of ventilation.
What to do
- Stop using the product immediately.
- Check model numbers if provided.
- Contact the manufacturer for instructions.
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Affected products
Fabian Therapy Evolution
Model: 7250.N
Lot: More than 10 numbers, contact manufacturer.
Fabian HFO Premature Infant and Pediatric Ventilator - Ventilator
Model: 7200
Lot: AH18BD-01037, AH18CD-01046, AH18ID-01306, AH18KD-01365, AI-00597, AI-00681, AI-00687, AL-00100, AL-00101
Why this matters
Serious injury or death due to lack of ventilation
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: AH18BD-01037, AH18CD-01046, AH18ID-01306, AH18KD-01365, AI-00597, AI-00681, AI-00687, AL-00100, AL-00101, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 7200, 7250.N
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Serious injury or death due to lack of ventilation
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Contact the manufacturer for instructions.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Serious injury or death due to lack of ventilation
When was this product recalled?
This product was recalled on May 26, 2021.
Is the Fabian brand affected by this recall?
Yes, Fabian products are affected by this recall. This recall involves Fabian HFO, +nCPAP evolution, and Therapy evolution ventilators sold in Canada. They are being recalled because a power board defect can cause the ventilator to shut down without an alarm. This could lead to serious injury or death due to lack of ventilation.